Case:62-year-old man sent from a nursing home with a three day history of a productive cough, intermittent fevers and today is a bit confused. The transfer notes include a history of congestive heart failure, COPD, gout, hypertension, type-2 diabetes, and mild dementia. CHF, COPD, gout, HTN, DM-II, and mild dementia. His vital signs are as follows: Temp 39.1C, heart rate 103, blood pressure 115/100, respiratory rate 26, Oxygen saturation Sat 92% and a normal blood sugar.

The patients in both groups were similar with respect to prognostic factors. Yes

All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No

All groups were treated equally except for the intervention. Yes

Follow-up was complete (i.e. at least 80% for both groups). Yes

All patient-important outcomes were considered. Yes

The treatment effect was large enough and precise enough to be clinically significant. Yes

Key Results: All groups were well balanced and similar. In this case the demographic and clinical characteristics nearly identical in both cohorts (EGDT n=796, usual care n=804).

No Significant Differences:

IV fluid volumes given in both arms (avg 2.5L)

Randomization times (avg. 2.7hrs after ED arrival),

Mean time to antibiotics (avg 70min; lungs & urinary most common sites of origin)

Positive blood culture rates (38% both groups).

Significant Differences:

More ICU admissions in EGDT group (87%) vs. usual care (76.9%),

More fluid given in first 6-hours in EGDT arm (diff approx 250cc),

Vasopressors 66.6% EGDT vs. usual care (57.8%),

Blood transfusion (13.6% EGDT vs. 7.0% usual),

Dobutamine (15.4% vs. 2.6%),

Higher MAP (76.5 EGDT vs. 75.3 usual).

No significant difference in all cause mortality at 90 days.

Primary Outcome: 90 day all-cause mortality

EGDT 18.6% vs. usual 18.8%

Secondary and Tertiary Outcomes:

ED length of stay shorter in EGDT (1.4hrs) vs. usual care (2.0hrs)

Vasopressor use EGDT (76.3%) vs. usual (65.8%),

No difference mean vasopressor infusion times.

No other significant differences in secondary or tertiary outcomes.

No difference in adverse event rates (7.1% EGDT vs. 5.3% usual).

This was a very well done study with very good methods. They had good randomization, multi-center and multi country. They did intention to treat analysis. There was >99% follow for both groups. Planned safety analysis at 50% enrolment. This was reviewed by a independent data and safety monitoring committee.

Only obvious and unavoidable issue was they were unable to blind physicians and patients due to nature of interventions. However, we feel that this would have favored EGDT and only strengthens the result accepting the null hypothesis of no superiority.

No clinically relevant differences in all primary, secondary or tertiary outcomes (although some are statistically different).

Our Conclusions Compared to Authors’: This is the second large 2014 sepsis resuscitation trial (ProCESS spring 2014) suggesting that aggressive EGDT protocols are not necessary to increase survival in septic shock patients, compared to “usual” care involving early recognition, IV fluid resuscitation and empiric antibiotics treatment.

This information confirms (as did ProCESS 2014) what many clinicians without EGDT resources/capabilities have hoped for and believed, that invasive resuscitation is not needed beyond liberal IV crystalloid resuscitation (>30cc/kg), broad-spectrum antibiotics, and serial lactate monitoring.

SGEM Bottom Line:Invasive EGDT-based sepsis resuscitation is not required compared to early recognition and liberal IV fluid resuscitation and empiric antibiotics in the septic patients.

Case Resolution: Having recognized the sepsis potential of this patient and confirming a high lactate, you initiate broad spectrum antibiotics for what is most likely a clinical pneumonia. You give aggressive fluid resuscitation with IV normal saline or ringers lactate. Then call your consultant to arrange admission to the intensive care unit.

What Do I Tell My Patients? We are going to give you lots of IV fluids, broad spectrum antibiotics and admit you to the hospital.

Keener Kontest: Winner last week was Dr. Chris Belcher a PGY1 Emergency Medicine resident from Kentucky. He knew the oldest hospital north of the Mexican boarder is the Hotel Dieu Hospital in Quebec City founded in 1637.

Listen to the podcast to hear this weeks keener question. If you know the answer send an email to TheSGEM@gmail.com with “keener” in the subject line. The first person to correctly answer the question will receive a cool skeptical prize.